NCT01361711

Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia

A Phase 2 Trial of Alemtuzumab-Ofatumumab Combination in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated chronic lymphocytic leukemia (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving alemtuzumab together with ofatumumab may kill more cancer cells

Detailed description

OBJECTIVES: I. To determine the efficacy and safety of alemtuzumab-ofatumumab combination treatment in previously untreated CLL. OUTLINE: Patients receive alemtuzumab subcutaneously (SC) three times a week in weeks 1-18 and ofatumumab intravenously (IV) over 4-6 hours on day 1 of weeks 3, 5, 7, 9, 11, 13, 15, and 17. After completion of study treatment, patients are followed up for up to 5 years.

Conditions

• Stage I Chronic Lymphocytic Leukemia
• Stage II Chronic Lymphocytic Leukemia
• Stage III Chronic Lymphocytic Leukemia
• Stage IV Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	alemtuzumab	Given SC
BIOLOGICAL	ofatumumab	Given IV
PROCEDURE	biopsy	Correlative studies

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-08-17
• Completion: 2027-05-01
• First posted: 2011-05-27
• Last updated: 2025-05-23
• Results posted: 2021-01-22

Locations

2 sites across 2 countries: United States, Sweden